Use of the LOK® Robotic Gait Trainer in the Early Rehabilitation of Children After an Acquired Brain Injury (ABI)

September 18, 2018 updated by: Holland Bloorview Kids Rehabilitation Hospital

Use of the LOK® Robotic Gait Trainer in the Early Rehabilitation of Children After an Acquired Brain Injury (ABI): A Feasibility Study - Part III

After an acquired brain injury (ABI), children often require extensive physiotherapy (PT) to help them relearn to walk. There is promising evidence in pediatric neuro-motor conditions of the possibility for brain activation pattern changes in response to repetitive, task-oriented functional gait training. Robotic-assisted gait training devices such as the Lokomat (LOK) allow this type of intensive walking retraining. The aim of this study is to assess the safety, feasibility and outcome possibilities linked to a LOK intervention given as 2 of the child's 4 PT weekly sessions over 8-weeks in the early stages of rehabilitation after an ABI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is Phase 3 of our three- year ABI Lokomat study . Phase 1 was conducted in 2016-2017 and was a single-group pre- and post-test feasibility study of the Lokomat in pediatric ABI inpatients and daypatients in which we enrolled 9 patient participants. The co-primary outcome measures for this first phase were the Gross Motor Function Measure (GMFM), Canadian Occupational Performance Measure (COPM) . Other measures of function (PEDI-CAT), gait (6 minute walk test and Timed up and GO) and individualized goals (Goal Attainment Scaling) were included. Study feasibility was evaluated via indicators such as enrollment, number of sessions completed, drop out rate, and adverse events. Phase 2 was conducted in 2017-2018 using the same core outcome set, and added a qualitative study component with child and parent and physiotherapist interviews for their perspective on the Lokomat experience and associated outcomes. The investigators enrolled 6 patient participants (quantitative and qualitative) and their caregivers (qualitative). Phase 3 will aim to enroll 6 to 8 more children to strengthen effect size estimates for the GMFM and COPM in particular (proposed co-primary outcome measures for future randomized controlled trial). The investigators will also add in an observational gait scale to measure potential changes in gait pattern/quality which investigators have noted in the first 2 years of the study, and pilot a measure of children's self-efficacy that the investigators will design for this study. Finally, the investigators will take a close look at motor learning strategies (MLS) used by the PTs in both LOK and PT sessions using the validated Motor Learning Strategies Rating Instrument (MLSRI) to begin to get a profile of comparative MLS use in gym-based PT and LOK sessions. The investigators will continue to study feasibility and add to the data from the first 2 phases the ABI LOK project.

Study Type

Interventional

Enrollment (Anticipated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be an inpatient or daypatient in the Brain Injury Rehabilitation program at Holland Bloorview Kids Rehabilitation Hospital with moderate or severe ABI
  • Be Gross Motor Function Classification System-equivalent III or IV with primary gait goals
  • Have any limb distribution of involvement (spasticity or hypotonicity). The physiotherapist (PT) and Lokomat (LOK) sessions (both about 45-minutes in length) will employ a motor learning strategies approach.
  • Have a femur length at least 21 cm (to fit robotic legs) and height no greater than 6' 3" to fit LOK frame
  • Be no more than 12 months post-ABI (i.e., still active rehab stage), and
  • Be expected by clinical team (confirmed by child's physician) to have at least 8 more weeks of inpatient or daypatient rehab
  • Be able to follow Gross Motor Function Measure instructions and participate in > 45 minutes of active PT (as judged by the child's PT)
  • Be able to reliably signal pain and discomfort using verbal or nonverbal signals (as assessed at the screening assessment) for LOK operation safety reasons.

Exclusion Criteria:

  • A seizure in the last 12 months,
  • Inability to tolerate full weightbearing
  • A knee flexion contracture > 20 degrees, knee valgus >40 degrees, hip subluxation > 40% migration percentage
  • Excessive tone or ataxic or dyskinetic movements may be an exclusion (would be determined at LOK set-up confirmation visit).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lokomat
16 sessions total. Provided by study PT twice weekly for 8 weeks.
Device: Lokomat
16 sessions total. Provided by study PT twice weekly for a period of 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Measure (GMFM-66)
Time Frame: Baseline, 8 weeks
Change from baseline in motor function on Gross Motor Function Measure (GMFM-66) at week 8
Baseline, 8 weeks
Canadian Occupational Performance Measure (COPM)
Time Frame: Baseline, 8 weeks
Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure at week 8
Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goal Attainment Scale (GAS)
Time Frame: Baseline, 8 weeks
Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS) at week 8. Three to five individualized walking-based activity/participation goals are set with child/parent/treating PT at baseline. Goal achievement level (score of -2 to+2) evaluated by treating PT with child/parent input at post-intervention assessment. GAS outcome (achievement) is measured by a standardized T-score that is a summary score(calculated from individual goal -2 to +2 scores) for the child's set of goals . Goal accomplishment at the targeted level (averaged across the goal set) is reflected by a T score = 50.0 + 5 with range of scores from ~ 25 to 85.
Baseline, 8 weeks
Gait speed (10 minute fastest walk test )
Time Frame: Baseline, 8 weeks
Change from baseline in Gait Speed (10 minute fastest walk test) at week 8
Baseline, 8 weeks
Observational Gait Scale
Time Frame: Baseline, 8 weeks

Change from baseline in Gait quality as measured on an observational gait scale at week 8.

Gait pattern evaluated via an observational 25-item scale (Total score /100 with higher scores indicating better pattern) that was constructed and validated in cerebral palsy by CoPI Wright at the research facility. Rating is from video of child's walking along a 7 metre distance.
Baseline, 8 weeks
The Pediatric Evaluation of Disability Inventory (PEDI-CAT)
Time Frame: Baseline, 8 weeks
Change from baseline in PEDI-CAT at week 8.
Baseline, 8 weeks
Movement Ability Self-efficacy Questionnaire (MASQ)
Time Frame: Baseline, week 8
Change from baseline in MASQ at week 8
Baseline, week 8
Gait Kinematics (measured on the GaitRite evaluation system)
Time Frame: Baseline, week 8
Change from baseline in gait kinematics as measured on the GaitRite evaluation system at week 8
Baseline, week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility indicator: Recruitment Rate
Time Frame: Monthly over 12 months through study completion
Recruitment rate (%) as measured by: # of participants enrolled / # of participants screened and eligible
Monthly over 12 months through study completion
Feasibility indicator: Retention Rate
Time Frame: Monthly over 12 months through study completion
Retention rate (%) as measured by: # of participants completing both baseline and follow-up assessment / total # of participants
Monthly over 12 months through study completion
Feasibility indicator: Protocol Adherence
Time Frame: Monthly over 12 months through study completion
Protocol adherence (%) as measured by: Number of sessions completed / 16 possible sessions
Monthly over 12 months through study completion
Motor Learning Strategies Rating Instrument (MLSRI)
Time Frame: Week 2-3, Week 6-7
Compare motor learning strategy (MLS) use in LOK and PT to explore how LOK use may affect motor skill acquisition post-ABI.
Week 2-3, Week 6-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Investigators

  • Principal Investigator: Ryan Hung, MD, MSc, Holland Bloorview Kids Rehabilitation Hospital
  • Principal Investigator: Virginia Wright, PT, PhD, Holland Bloorview Kids Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-771

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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